Quality Assurance Engineer I
About The Position
About the Role Were seeking a Quality Assurance Engineer I to support critical Quality Management System functions within our manufacturing operations. This role is ideal for an early career engineer looking to make an immediate impact in a fast-paced medical device environment. Youll help manage supplier quality, drive corrective actions, support compliance, and contribute to continuous improvement initiatives that directly influence patient outcomes. Key Responsibilities Support production teams on all manufacturing-related quality needs Administer supplier management processes Coordinate equipment calibration and preventive maintenance tracking Manage CAPA documentation, follow-up, and closure Maintain training compliance records Enter and track customer complaints in accordance with regulatory requirements Support quality metrics reporting and system activity tracking Identify and implement process improvement opportunities Assist with documentation simplification, workflow charts, data analytics, and general administrative support Perform other quality engineering tasks as assigned Qualifications Minimum Requirements Bachelors degree in engineering (preferably Mechanical or Biomedical) from an accredited institution Experience in the medical device industry (21 CFR 820 or ISO 13485); internships or project work in quality, manufacturing, or product development preferred Key Competencies Ability to interpret technical drawings and specifications Strong analytical thinking and problem-solving skills Excellent verbal and written communication Comfortable working in a fast-paced, dynamic environment Proficient in Microsoft Word and Excel Strong collaborator with a do the right thing mindsetunafraid to surface and address quality concerns Meticulous attention to detail, particularly with documentation Working knowledge of programming languages (Python, JavaScript, SQL, or Visual Basic) a plus Why Join Us? This is a unique opportunity to grow your engineering career within a highly innovative medical device organization. Youll gain exposure across operations, quality systems, and continuous improvement while helping deliver life-changing solutions to our customers.
Requirements
- Bachelors degree in engineering (preferably Mechanical or Biomedical) from an accredited institution
- Experience in the medical device industry (21 CFR 820 or ISO 13485); internships or project work in quality, manufacturing, or product development preferred
- Ability to interpret technical drawings and specifications
- Strong analytical thinking and problem-solving skills
- Excellent verbal and written communication
- Comfortable working in a fast-paced, dynamic environment
- Proficient in Microsoft Word and Excel
- Strong collaborator with a do the right thing mindsetunafraid to surface and address quality concerns
- Meticulous attention to detail, particularly with documentation
Nice To Haves
- Working knowledge of programming languages (Python, JavaScript, SQL, or Visual Basic) a plus
Responsibilities
- Support production teams on all manufacturing-related quality needs
- Administer supplier management processes
- Coordinate equipment calibration and preventive maintenance tracking
- Manage CAPA documentation, follow-up, and closure
- Maintain training compliance records
- Enter and track customer complaints in accordance with regulatory requirements
- Support quality metrics reporting and system activity tracking
- Identify and implement process improvement opportunities
- Assist with documentation simplification, workflow charts, data analytics, and general administrative support
- Perform other quality engineering tasks as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
101-250 employees
